MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM; TRANSCATHETER SEPTAL OCCLUDER

Model Number	9-ASD-MF-030
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported on (b)(6) 2025, a 25mm amplatzer multi-fenestrated septal occluder - cribriform was selected for implant using an 8f amplatzer trevisio intravascular delivery system to treat a multi-fenestrated atrial septal defect.During implant the occluder took on a bulbous shape.The occluder was re-captured and re-deployed, however the occluder the bulbous shape remained.The occluder was removed from the patient.The occluder was pushed out of the loader multiple times however the bulbous shape still remained.A new 30mm amplatzer multi-fenestrated septal occluder - cribriform was selected for implant.During implant the second occluder also took on a bulbous shape.The occluder was removed from the patient.The devices were never released from the delivery cable.There were no angulations or kinks noted on the delivery system.The patient remained hemodynamically stable throughout the procedure.There were no adverse effects to the patient.The patient status was stable.
Event or Problem Description
It was reported on (b)(6) 2025 a 25mm amplatzer multi-fenestrated septal occluder - cribriform was selected for implant using an 8f amplatzer trevisio intravascular delivery system to treat a multi-fenestrated atrial septal defect.During implant the occluder took on a bulbous shape.The occluder was re-captured and re-deployed, however the occluder the bulbous shape remained.The occluder was pushed out of the loader multiple times however the bulbous shape still remained.The occluder was implanted.A new 30mm amplatzer multi-fenestrated septal occluder - cribriform was selected for implant.During implant the second occluder also took on a bulbous shape.The occluder was removed from the patient.The device was never released from the delivery cable.There were no angulations or kinks noted on the delivery system.The patient remained hemodynamically stable throughout the procedure.There were no adverse effects to the patient.The patient status was stable.
Additional Manufacturer Narrative
An event of device deformity was reported.A returned device inspection could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the available information, the cause for the reported device deformity could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22964806
• Report Number: 2135147-2025-04964
• Device Sequence Number: 18420422
• Product Code: MLV
• UDI-Device Identifier: 00811806010304
• UDI-Public: (01)00811806010304(17)300131(10)10708142
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-ASD-MF-030
• Device Catalogue Number: 9-ASD-MF-030
• Device Lot Number: 10708142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8F AMPLATZER TREV [9-ATV08F45/80, LOT: 10739248].
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 71 KG